BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DUREPAIR

    MDR report key: 23479628 · Received November 5, 2025

    Report

    Report Number
    3004170064-2025-00006
    Event Type
    Injury
    Date Received
    November 5, 2025
    Report Date
    November 5, 2025
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    GXQ
    PMA / PMN Number
    K063117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL HEALTH EFFECT - CLINICAL CODES: E0112. E0101. E0131. E0107. E0122. E1621. DUREPAIR WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY REPORTED. ALTHOUGH THIS DEVICE IS UNDER THE SCOPE OF THE ENDOTOXIN RECALL, THERE IS NO EVIDENCE TO SUGGEST ENDOTOXIN CONTAMINATION IS A LIKELY CAUSE AS THE REPORTED SYMPTOMS DO NOT CORRESPOND WITH THE HARMS FROM THAT PARTICULAR HAZARD. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    IT WAS ALLEGED: IN THE SUMMER OF 2022, A PATIENT WAS DIAGNOSED WITH HYPEROSTOTIC INTRAOSSEOUS MENINGIOMA. ON (B)(6) 2022, THE PATIENT UNDERWENT A CRANIECTOMY AND TUMOR RESECTION WITH 3D CRANIOPLASTY WHICH REQUIRED A DURA EXCISION AND REPAIR. DURING THIS SURGERY, SURGEON UTILIZED THE MEDTRONIC DUREPAIR DURA REGENERATION MATRIX IMPLANT (UNKNOWN ID). LESS THAN A MONTH LATER, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF INCREASED TENDERNESS AT THE INCISION SITE AND FRONTAL PAIN, AS WELL AS ABNORMAL DRAINAGE FROM THE INCISION SITE. ON (B)(6), 2022, THE PATIENT WAS RUSHED TO SURGERY AND UNDERWENT A CRANIOPLASTY FOR A SUSPECTED INFECTED WOUND SITE. DURING THAT SURGERY, HOWEVER, NO EVIDENCE OF INFECTION WAS FOUND. TO BE SAFE, A SAMPLE OF TISSUE WAS REMOVED AND SENT TO PATHOLOGY FOR TESTING AND THE PATHOLOGY SHOWED NO ORGANISMS ON ROUTINE STAINS OF THE EXPLANTED SPECIMEN. IN THE MONTHS FOLLOWING HER DISCHARGE, THE PATIENT HAD FLUID ACCUMULATION ON TOP OF HER INCISION SITE AND ALSO EXPERIENCED A RANGE OF SYMPTOMS, INCLUDING BUT NOT LIMITED TO, HEADACHES, FATIGUE, BRAIN FOG, DIZZINESS, DIFFICULTY BALANCING, DIFFICULTIES WITH SPEECH, AND OTHER COGNITIVE AND PHYSICAL AILMENTS TO THE POINT WHERE SHE WAS UNABLE TO PERFORM THE FUNCTIONS OF HER JOB. ON (B)(6) 2024, THE PATIENT HAD A FOLLOW-UP APPOINTMENT, AND IT WAS RECOMMENDED TO UNDERGO AN EXPLORATION OF HER DURAPLASTY TO REPLACE HER ALLOGRAFT WITH A 3D PRINTED CUSTOM IMPLANT TO HELP WITH THE FLUID ACCUMULATION. ON (B)(6) 2024, AFTER THE 3D CUSTOM IMPLANT WAS COMPLETED, THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION CRANIOPLASTY AND DURAPLASTY DUE TO A PERSISTENT PSEUDOMENINGOCELE AND PAINFUL MESH ("THE PATCH"). DURING THE SURGERY, IT WAS FOUND THAT THE DUREPAIR MATRIX HAD ERODED AND THE PATIENT'S LEFT BRAIN WAS EXPOSED. THE ERODED DUREPAIR MATRIX WAS THEN REMOVED AND REPLACED WITH A CUSTOM IMPLANT. DESPITE THIS ADDITIONAL SURGICAL INTERVENTION, THE PATIENT'S HEADACHES, HEAD PRESSURE, BRAIN FOG, AND DIZZINESS, AMONG OTHER SYMPTOMS, PERSISTED. ADDITIONALLY, WHILE THE FLUID ACCUMULATION INITIAL RESOLVED BY (B)(6) 2024, THE FLUID ACCUMULATION RETURNED IN (B)(6) 2024, AND IT WAS RECOMMENDED TO DO A SHUNT PLACEMENT. ON (B)(6) 2024, THE PATIENT UNDERWENT ANOTHER SURGERY TO PLACE A STRATA VALVE SHUNT SYSTEM. THE PATIENT SUBSEQUENTLY SUFFERED COMPLICATIONS, INCLUDING BUT NOT LIMITED TO, HEADACHES, FATIGUE, BRAIN FOG, HEAD PRESSURE, FLUID ACCUMULATION, CONCENTRATION ISSUES, SLOWED SPEECH, SLOWED MOVEMENT, ISSUES WITH GRIP STRENGTH, AND DIFFICULTY WITH DAILY ACTIVITIES, WHICH ULTIMATELY REQUIRED MULTIPLE SURGICAL INTERVENTIONS. AS A RESULT OF THESE LIFE-ALTERING AND, IN SOME CASES, PERMANENT INJURIES, THE PATIENT HAS SUFFERED SEVERE EMOTIONAL PAIN AND INJURY AND HAS SUFFERED AND WILL SUFFER APPREHENSION OF INCREASED RISK FOR INJURIES, INFECTIONS, PAIN, MENTAL ANGUISH, DISCHARGE, AND MULTIPLE CORRECTIVE SURGERIES AS A RESULT OF IMPLANTATION OF DUREPAIR MATRIX PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606331 UNKNOWN DUREPAIR DUREPAIR GXQ TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention